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Individual Molecular MRD Monitoring for MDS Patients After Allo-SCT

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ClinicalTrials.gov Identifier: NCT02872662
Recruitment Status : Recruiting
First Posted : August 19, 2016
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Nordic MDS Group

Brief Summary:
This study aims to develop highly sensitive methods for early detection of relapse based on the patients unique mutations. Initially, a mutational screen is being performed. Primers directed against these mutations will be constructed and presence of mutations will be followed in bone marrow and blood frequently after transplantation.

Condition or disease
MDS SCT MRD

Detailed Description:

This study aims to develop highly sensitive methods for early detection of relapse based on the patients unique mutations.

Screening of mutations In collaboration with Department for clinical genetics, Uppsala, an initial screening of mutations will be performed using the commercial TrueSight© sequencing panel which includes 54 genes recurrently mutated in myeloid diseases. Based on the mutations identified, PCR-primers for all patient-specific mutations will be designed. Patients without any mutation will be excluded from the study. The mutational screen is performed as soon as a patient is being identified as a potential candidate for allogeneic stem cell transplantation (SCT) and evaluated for most optimal pre-SCT treatment. The patient is included in the study before the bone marrow sampling preceding SCT. In case a mutational screen has not been performed before pre-SCT MDS treatment, a mutational screen from the diagnostic national biobank sample (peripheral blood) can be performed.

MRD surveillance After the transplantation, peripheral blood samples will be collected once monthly; and bone marrow samples will be collected at month 1, 3, 6 after SCT followed by sampling every third month until relapse or death. The samples are sent to Biobanking and Molecular Resource Infrastructure of Sweden (bbmri) who will extract DNA and store the samples. By using the highly sensitive digital-PCR method the investigators will determine the size of the different clones at the different time points. In addition to biobanking of DNA, bbmri will collect and vital froze mononuclear cells (MNCs) to be used for experimental studies.

Statistics Landmark analyses will be performed at different time points after SCT, using presence of MRDs as a risk factor included in a multivariate analysis. Furthermore, the investigators will calculate sensitivity, specificity and predictive value for MRDs in relation to relapse. For each specific mutation, with high enough frequency in the cohort, the investigators will define cut-off values of the MRD where relapse is impending.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Individual Molecular Minimal Residual Disease (MRD) Monitoring for Patients With MDS and Mixed MDS/MPN Treated With Allogeneic Stem Cell Transplantation
Actual Study Start Date : August 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019



Primary Outcome Measures :
  1. Level of variant allele frequency (MRD) associated with full hematological relapse [ Time Frame: From inclusion up to end of study (August 2019) ]
    MRD is a quantative variable defined as variant allele frequency of patient-specific mutations. The association between MRD and relapse and survival will be studied.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
200 consecutive MDS patients undergoing allogeneic SCT
Criteria

Inclusion Criteria:

  1. MDS with allo SCT to be performed
  2. One or more mutations identified
  3. Written informed consent

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872662


Contacts
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Contact: Magnus Tobiasson, PhD 0046858580000 magnus.tobiasson@ki.se

Locations
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Denmark
Department of Hematology, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Department of Hematology, Rigshospitalet Univsersity Hospital Recruiting
Copenhagen, Denmark
Contact: Lars Kjeldsen         
Norway
Department of Medcine, Haukeland University Hospital Recruiting
Bergen, Norway
Contact: Astrid Olsnes Kittang         
Department of Hematology, Rikshospitalet University Hospital Recruiting
Oslo, Norway, 0027
Sweden
Department of Hematology and Coagulation, Sahlgrenska University hospital Recruiting
Gothenburg, Sweden, 413 45
Department of Hematology, Lund University Hospital Recruiting
Lund, Sweden, 221 85
Department of Hematology, Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Eva Hellstrom-Lindberg         
Department of Hematology, Akademiska University Hospital Recruiting
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Nordic MDS Group
Investigators
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Principal Investigator: Eva Hellström-Lindberg, Prof Karolinska Institutet

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Responsible Party: Nordic MDS Group
ClinicalTrials.gov Identifier: NCT02872662     History of Changes
Other Study ID Numbers: NMDSG14B
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Mutational data, MRD and clinical data is planned to be published

Additional relevant MeSH terms:
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Neoplasm, Residual
Neoplastic Processes
Neoplasms
Pathologic Processes